13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
C. ALBICANS PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
FDA 510(k)
FDA Class 2
·Cardiovascular
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - DEPUY RAYNHAM DIVISION·Product code HSH·June 17, 2008
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 12, 2011
BD CONNECTA STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·November 26, 2020
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
GORE® PROPATEN® VASCULAR GRAFT
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015